Short-term Treatment Satisfaction in Hidradenitis Suppurativa Patients Initiated on Cosentyx in Routine Clinical Practice in Saudi Arabia
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Secukinmab.
- Кому может быть актуально
- Состояния в реестре: Hidradenitis Suppurativa (HS). Базовые параметры: 18 лет — 99 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Саудовская Аравия
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Survey Assessing Prospective Patient's Short-term Treatment Satisfaction and Quality of Life in Patients With Hidradenitis Suppurativa Initiated on Cosentyx (Secukinumab) in Routine Clinical Practice in Saudi Arabia: ILLUMINATE-SA
Обзор
This study aims to assess the treatment satisfaction of HS patients newly started on secukinumab in Saudi Arabia, in terms of patient reported convenience, perceived safety, perceived effectiveness and global treatment satisfaction as measured by the treatment satisfaction questionnaire for medication (TSQM) at week 24 among moderate to severe HS patients.
Подробное описание
This is a 24-week longitudinal single arm prospective study based on data collected from electronic medical records (EMRs) and patient-reported outcomes questionnaires (TSQM, DLQI, and NPRS-11) to evaluate patient-reported satisfaction and early QoL experiences among HS adult patients who are newly administering Secukinumab as per routine clinical practice.
Data will be captured from both data sources (EMRs and Questionnaires) at the following time points (+/- 1 month):
* Baseline (index date: initiation of Secukinumab), * 24 weeks.
This is in line with the frequency of routine follow-up visits and as per the standard of care to report on pre-defined outcomes in a representative HS population across Saudi Arabia.
Вмешательства
- Другое Secukinmab
This is an observational study. There is no treatment allocation. The decision to initiate secukinumab will be based solely on clinical judgement.
Первичные конечные точки
- Mean Score in the Treatment Satisfaction Questionnaire (TSQM) [Срок оценки: Week 24]
Вторичные конечные точки (12)
- Mean change from baseline in patient-reported QoL via the Dermatology Life Quality Index (DLQI) Questionnaire [Срок оценки: Baseline, week 24]
- Mean change from baseline to week 24 in the Numeric Pain Rating Scale (NPRS-11) [Срок оценки: Baseline, week 24]
- Baseline characteristics-age [Срок оценки: Baseline]
- Baseline characteristics - Ethnicity [Срок оценки: Baseline]
- Baseline characteristics - Socio-economic status [Срок оценки: Baseline]
- Baseline characteristics - smoking status [Срок оценки: Baseline]
- Baseline characteristics - Family history of HS [Срок оценки: Baseline]
- Baseline characteristics - Duration of the disease [Срок оценки: Baseline]
- Baseline characteristics - Previous HS-related treatment [Срок оценки: Baseline]
- Baseline characteristics - previous HS-related surgeries [Срок оценки: Baseline]
- Baseline characteristics - Current or previous use of antibiotic treatment [Срок оценки: Baseline]
- Baseline characteristics - Time since diagnosis to first treatment and secukinumab treatment [Срок оценки: Baseline]
Критерии участия
Критерии включения
- Male or Female adult patients ≥18 years of age at the time of data collection.
- Patient with a confirmed diagnosis of active moderate to severe HS.
- Secukinumab naive patients (first dose to coincide within one month of the signature of the informed consent) as per locally approved label.
- Patients can be using antibiotics or have undergone surgery as per routine clinical practice.
- Patients agree to sign an informed consent form (ICF) to be able to complete the questionnaires.
Критерии исключения
- Patients not fulfilling any of the above-mentioned inclusion criteria.
- Patient's refusal to be included in the study or refusal to sign the ICF.
- A history of off-label indication uses of biological treatment or JAK inhibitor.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Саудовская Аравия · 4 центра
- Novartis Investigative Site — Riyadh
- Novartis Investigative Site — Jeddah
- Novartis Investigative Site — Jeddah
- Novartis Investigative Site — Riyadh
Идентификаторы
NCT: NCT06785779 · CAIN457MSA01